PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Dyspnea in Patients with Non-malignant Respiratory Diseases Study

PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Dyspnea in Patients with Non-malignant Respiratory Diseases Study - PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Dyspnea in Patients with Non-malignant Respiratory Diseases Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049267

Enrollment

200

Registered

2022-10-19

Start date

2022-10-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-malignant respiratory diseases

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Hospitalized adult patients with non-malignant respiratory diseases 2. Patients who will receive regular opioids (morphine, codeine, oxycodone, hydromorphone, fentanyl) for dyspnea (IPOS > 1 in the past day)

Exclusion criteria

Exclusion criteria: 1. Patients who are scheduled to undergo an intervention (e.g., chest drainage of pneumothorax or pleural effusion, introduction or withdrawal of noninvasive respiratory management techniques such as NPPV or HFNC) that could cause a change in dyspnea intensity within 2 days of enrollment 2. Patients on invasive ventilation 3. Patients with malignant tumors in the thoracic cavity

Design outcomes

Primary

Measure	Time frame
Percentage of patients with at least 1 decrease in dyspnea NRS 24 hours after initiation of regular opioid therapy	—

Secondary

Measure	Time frame
Percentage of patients with dyspnea IPOS of 1 or less 24 hours after starting regular opioid therapy for dyspnea Change in dyspnea NRS (now) 24 hours after starting regular opioids for dyspnea Change in dyspnea NRS (worst value in previous 24 hours) in 24 hours after starting regular opioids for dyspnea Percentage of improvement in dyspnea by patient subjective measures 24 hours after starting regular opioids for dyspnea Opioid-related adverse events in the first 24 hours after starting regular opioids for dyspnea	—

Measure

Time frame

Percentage of patients with dyspnea IPOS of 1 or less 24 hours after starting regular opioid therapy for dyspnea Change in dyspnea NRS (now) 24 hours after starting regular opioids for dyspnea Change in dyspnea NRS (worst value in previous 24 hours) in 24 hours after starting regular opioids for dyspnea Percentage of improvement in dyspnea by patient subjective measures 24 hours after starting regular opioids for dyspnea Opioid-related adverse events in the first 24 hours after starting regular opioids for dyspnea

—

Countries

Japan

Contacts

Public ContactYoshinobu Matsuda

National Hospital Organization Kinki-Chuso Chest Medical Center Department of Psychosomatic Internal Medicine

matsuda.yoshinobu.tx@mail.hosp.go.jp0722523021

Outcome results